A Study of Non-Small Cell Lung Cancer (NSCLC) Patients Receiving Second-Line Nivolumab Monotherapy in Asia

NCT03195491 | Completed Phase 3 Results

• 1 other identifier: CA209-870
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 30

Brief Summary

The purpose of this study is to investigate the safety of patients in Asia with Non-Small Cell Lung Cancer (NSCLC)who are treated with Nivolumab monotherapy as a second line or third line treatment.

Conditions

Lung Cancer; Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Number of Non-HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events

  Number of non-HBV participants experiencing high grade (combined CTCAE v4 Grade 3-4 and Grade 5) treatment-related select adverse events in non-HBV infected participants. To evaluate safety and tolerability in non-HBV infected participants with advanced or metastatic non-small cell lung cancer (NSCLC) who have progressed during or after one prior systemic therapy and are treated with nivolumab monotherapy with an infusion duration of 30 minutes. Adverse events are graded on a scale from 1 to 5, with Grade 1 being mild and asymptomatic; Grade 2 is moderate requiring minimal, local or noninvasive intervention; Grade 3 is severe or medically significant but not immediately life-threatening; Grade 4 events are usually severe enough to require hospitalization; Grade 5 events are fatal.

  From first dose up to 100 days post dose, up to approximately 36 months

Secondary Outcomes (10)

• Number of HBV Participants Experiencing High Grade Treatment-Related Select Adverse Events

  From first dose up to 100 days post dose, up to approximately 36 months

• Number of Participants Experiencing Adverse Events (AEs)

  From first dose up to 100 days post dose, up to approximately 36 months

• Overall Survival (OS)

  From the first dose up to the date of death. Participants without documentation of death will be censored on the late date known to be alive, up to approximately 32 months

• Progression-Free Survival (PFS)

  From the first dose up to the date of the first documented tumor progression (per RECIST 1.1) or death due to any cause, up to approximately 30 months

• Number of Participants Experiencing Laboratory Abnormalities in Specific Liver Tests

  From first dose up to 100 days post last dose, up to approximately 36 months

Study Arms (1)

Monotherapy

EXPERIMENTAL

Nivolumab administered every two weeks

Biological: Nivolumab

Interventions

Nivolumab BIOLOGICAL

Intravenous infusion administered over 30 minutes at 240 mg

Also known as: Opdivo, BMS-936558

Monotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Advanced metastatic stage IIIB/IV NSCLC (Nonsquamous and squamous)
• to 2 prior systemic therapies
• Eastern Cooperative Oncology Group (ECOG) Performance Status of less than or equal to 1
• Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI)
• Prior radiotherapy or radiosurgery must have been completed at least 2 weeks prior to starting study treatment

You may not qualify if:

• Women with a positive pregnancy test at enrollment or prior to administration of study medication
• Participants with active central nervous system metastases
• Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of first dose of study drug
• Participants with previous malignancies are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required or anticipated to be required during the study period
• Participants with carcinomatous meningitis

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (30)

Local Institution

Beijing, Beijing Municipality, 100001, China

Location

Local Institution

Beijing, Beijing Municipality, 100142, China

Location

Local Institution

Beijing, Beijing Municipality, 100730, China

Location

Local Institution

Beijing, Beijing Municipality, 101149, China

Location

Local Institution

Fuzhou, Fujian, 350014, China

Location

Local Institution

Guangzhou, Guangdong, 510080, China

Location

Local Institution

Beijingcun, Hebei, 100031, China

Location

Local Institution

Harbin, Heilongjiang, 150081, China

Location

Local Institution

Zhengzhou, Henan, 450008, China

Location

Local Institution

Wuhan, Hubei, 430022, China

Location

Local Institution - 0017

Changsha, Hunan, 410013, China

Location

Local Institution

Nanjing, Jiangsu, 210002, China

Location

Local Institution

Nanjing, Jiangsu, 210008, China

Location

Local Institution

Changchun, Jilin, 130012, China

Location

Local Institution

Changchun, Jilin, 130021, China

Location

Local Institution

Xi'an, Shan3xi, 710038, China

Location

Local Institution

Jinan, Shandong, 250031, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200025, China

Location

Local Institution

Shanghai, Shanghai Municipality, 200032, China

Location

Local Institution

Tianjin, Tianjin Municipality, 300222, China

Location

Local Institution

Ürümqi, Xinjiang, 830011, China

Location

Local Institution

Hangzhou, Zhejiang, 310000, China

Location

Local Institution

Hangzhou, Zhejiang, 310003, China

Location

Local Institution

Hangzhou, Zhejiang, 310022, China

Location

Local Institution

Guangzhou, China

Location

Local Institution

Shanghai, 200030, China

Location

Local Institution

Shanghai, 200032, China

Location

Local Institution

Shenyang, 110042, China

Location

Local Institution

Bangkok, 10700, Thailand

Location

Local Institution

Khon Kaen, 40002, Thailand

Location

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Nivolumab

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: June 22, 2017
• Study Start: December 25, 2017
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: July 18, 2024
• Results First Posted: July 18, 2024

Record last verified: 2024-01

Locations

CN (28); TH (2)